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Food & drugs

UPDATE: Perform Only Contained Morcellation When Laparoscopic Power Morcellation Is Appropriate: FDA Safety Communication

30-12-2020

This update to the February 2020 safety communication provides information on the final guidance, Product Labeling for Laparoscopic Power...

Product safety

Target Recalls Infant Rompers Due to Choking Hazard

30-12-2020

 The snaps can break or detach from the rompers, posing a choking, laceration and pinching hazards to children.

Product safety

Target Recalls Infant-Toddler Girl’s One-Piece Rashguard Swimsuits Due to Choking Hazard

30-12-2020

The snaps can break or detach from the suits, posing choking and laceration hazards to children.

Food & drugs

2020 Safety Communications

29-12-2020

The FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and...

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Food & drugs

Potential for False Positive Results with Antigen Tests for Rapid Detection of SARS-CoV-2 - Letter to Clinical Laboratory Staff

03-11-2020

Laboratories should expect some false positive results when screening large populations with a low prevalence of COVID-19 infection.

Food & drugs

Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 750 mg, Due to N-N

02-11-2020

Kansas City, Missouri, Nostrum Laboratories, Inc. is voluntarily recalling 2 (two) lots of Metformin HCl Extended Release Tablets, USP 750 mg to the...

Food & drugs

Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 750 mg, Due to N-N

02-11-2020

Kansas City, Missouri, Nostrum Laboratories, Inc. is voluntarily recalling 2 (two) lots of Metformin HCl Extended Release Tablets, USP 750 mg to the...

Food & drugs

Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 500 mg, Due to N-N

02-11-2020

Nostrum Laboratories, Inc. is voluntarily recalling 2 (two) lots of Metformin HCl Extended Release Tablets, USP 500 mg to the consumer level. The...

News

West Michigan Urogynecologist Sentenced to Prison for Healthcare Fraud and Adulteration of Medical Devices

30-10-2020

FDA OCI, West Michigan, urogynecologist, sentence, 57 months prison, healthcare fraud, adulterated medical device, Roger Beyer MD, health care...

News

Nicholasville Compounding Pharmacy and Its Owner Plead Guilty to Unlawful Distribution of Prescription Drugs

30-10-2020

Nicholasville KY, Jeremy Delk, Tailor Made Compounding, pharmacy, guilty plea, unlawful distribution, prescription drugs, unapproved new drugs,...

News

Connecticut Nurse Charged with Tampering with Liquid Morphine

30-10-2020

Danielle Work, Stafford Springs CT, nurse, tampering, liquid morphine, Governor's Center, nursing facility, diluting, charges, prescription drugs,

Food & drugs

Natural Grocers Issues Voluntary Recall on Organic Elderberries Due to Potential Presence of Salmonella

29-10-2020

Vitamin Cottage Natural Food Markets, Inc., a Lakewood, Colorado-based natural grocery retailer, is voluntarily recalling Natural Grocers Brand...

Food & drugs

Baxter Issues Urgent Device Correction to Reinforce Important Safety Information Regarding Cleaning Practices of all Sigma Spec

29-10-2020

Baxter International Inc. announced today it has issued an Urgent Device Correction to reinforce important safety information regarding cleaning...

Product safety

Gorilla Commerce Recalls Oven Liners Due to Risk of Carbon Monoxide Poisoning (Recall Alert)

29-10-2020

If the oven liner is not cut or configured for the exact specifications of the oven and it is placed over any vents or other openings in the oven,...

Product safety

Serena & Lily Recalls Nash Convertible Cribs Due to Injury Hazard (Recall Alert)

29-10-2020

The leg can become partially detached from the crib’s headboard and footboard, posing an injury hazard.

Product safety

Mueller Austria Recalls Onion Choppers Due to Serious Laceration Hazard

29-10-2020

The product’s locking tab can detach from the rest of the unit during use, causing hands and fingers to slide into the blades.